Respiratory pressure therapy system with nebulising humidifier

ABSTRACT

An apparatus for treating a respiratory disorder in a patient, includes a respiratory pressure therapy device that generates a flow of air at positive pressure for treating the respiratory disorder. An air circuit transports the flow of air generated by the respiratory pressure therapy device to a patient interface. A nebuliser module is located at or adjacent to a proximal end of the air circuit to nebulise a liquid to form a nebula of the liquid. The nebula is admitted into the flow of air generated by the respiratory pressure therapy device. A vaporiser is located at the distal end of the air circuit to receive and vaporise the nebula to form a humidified flow of air.

This application is a continuation of U.S. patent application Ser. No.16/328,013 filed Feb. 25, 2019, which is the U.S. national phase ofInternational Application No. PCT/AU2017/050912 filed Aug. 28, 2017which designated the U.S. and claims priority to AU Patent ApplicationNo. 2016903417 filed Aug. 26, 2016, the entire contents of each of whichare hereby incorporated by reference.

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

BACKGROUND OF THE TECHNOLOGY 1.1 Field of the Technology

The present technology relates to one or more of the detection,diagnosis, treatment, prevention and amelioration of respiratory-relateddisorders. The present technology also relates to medical devices orapparatus, and their use.

1.2 Description of the Related Art 1.2.1 Human Respiratory System andits Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

A range of respiratory disorders exist. Certain disorders may becharacterised by particular events, e.g. apneas, hypopneas, andhyperpneas.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA),Cheyne-Stokes Respiration (CSR), respiratory insufficiency, ObesityHyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease(COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

A range of therapies have been used to treat or ameliorate suchconditions. Furthermore, otherwise healthy individuals may takeadvantage of such therapies to prevent respiratory disorders fromarising. However, these have a number of shortcomings.

1.2.2 Therapy

Various therapies, such as Continuous Positive Airway Pressure (CPAP)therapy, Non-Invasive Ventilation (NIV) and Invasive Ventilation (IV)have been used to treat one or more of the above respiratory disorders.

1.2.3 Treatment Systems

These therapies may be provided by a treatment system or device. Atreatment system may comprise a Respiratory Pressure Therapy device (RPTdevice), an air circuit, a humidifier, a patient interface, and datamanagement.

1.2.3.1 Patient Interface

A patient interface may be used to interface respiratory equipment toits wearer, for example by providing a flow of air to an entrance to theairways. The flow of air may be provided via a mask to the nose and/ormouth, a tube to the mouth or a tracheostomy tube to the trachea of apatient. Depending upon the therapy to be applied, the patient interfacemay form a seal, e.g., with a region of the patient's face, tofacilitate the delivery of gas at a pressure at sufficient variance withambient pressure to effect therapy, e.g., at a positive pressure ofabout 10 cmH₂O relative to ambient pressure. For other forms of therapy,such as the delivery of oxygen, the patient interface may not include aseal sufficient to facilitate delivery to the airways of a supply of gasat a positive pressure of about 10 cmH₂O.

1.2.3.2 Respiratory Pressure Therapy (RPT) Device

A respiratory pressure therapy (RPT) device may be used to deliver oneor more of a number of therapies described above, such as by generatinga flow of air for delivery to an entrance to the airways. The flow ofair may be pressurised. Examples of RPT devices include a CPAP deviceand a ventilator.

1.2.3.3 Vent Technologies

Some forms of treatment systems may include a vent to allow the washoutof exhaled carbon dioxide. The vent may allow a flow of gas from aninterior space of a patient interface, e.g., the plenum chamber, to anexterior of the patient interface, e.g., to ambient.

The vent may comprise an orifice and gas may flow through the orifice inuse of the mask. Many such vents are noisy. Others may become blocked inuse and thus provide insufficient washout. Some vents may be disruptiveof the sleep of a bed partner 1100 of the patient 1000, e.g. throughnoise or focused airflow.

ResMed Limited has developed a number of improved mask venttechnologies. See International Patent Application Publication No. WO1998/034,665; International Patent Application Publication No. WO2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application PublicationNo. US 2009/0050156; US Patent Application Publication No. 2009/0044808.

1.2.3.4 Humidifier

Delivery of a flow of air without humidification may cause drying ofairways. The use of a humidifier with an RPT device and the patientinterface produces humidified gas that minimizes drying of the nasalmucosa and increases patient airway comfort. In addition in coolerclimates, warm air applied generally to the face area in and about thepatient interface is more comfortable than cold air.

A range of artificial humidification devices and systems are known,however they may not fulfil the specialised requirements of a humidifierfor medical use, e.g. a medical humidifier.

Medical humidifiers are used to increase humidity and/or temperature ofthe flow of air in relation to ambient air when required, typicallywhere the patient may be asleep or resting (e.g. at a hospital). Amedical humidifier for bedside placement may be small. A medicalhumidifier may be configured to only humidify and/or heat the flow ofair delivered to the patient without humidifying and/or heating thepatient's surroundings. Room-based systems (e.g. a sauna, an airconditioner, or an evaporative cooler), for example, may also humidifyair that is breathed in by the patient, however those systems would alsohumidify and/or heat the entire room, which may cause discomfort to theoccupants. Furthermore medical humidifiers may have more stringentsafety constraints than industrial humidifiers

While a number of medical humidifiers are known, they can suffer fromone or more shortcomings. Some medical humidifiers may provideinadequate humidification, some are difficult or inconvenient to use bypatients.

In certain prior art medical humidifiers, condensation in the aircircuit can be a problem for patients. If water condenses in the aircircuit while a patient is wearing the system, some water may enter thepatient's airways. In some cases, water may flow back towards arespiratory therapy device, and/or the humidifier, which may potentiallythen create a risk of damaging or interfering with an operation of thedevice and/or the humidifier. For example, water may interfere withinternal electronics, occlude a flow path, occlude a sensing port, leakand create a hazard, and/or create ‘gurgling’ noise as it is splashedabout by the flow of air.

To mitigate this risk, the air circuit may be heated in some instancesof the prior art. However, this may increase a cost and complexity ofthe air circuit, as well as decreasing an overall efficiency of the RPTsystem, as heat from the air circuit is lost to the ambient due to thetemperature difference between the heated air circuit and the ambient.This may lead to an increase in cost/bulk of the therapy system,including from an increased power requirements to power the heated aircircuit.

Furthermore, some prior art humidifiers may suffer from a slow responsetime, for example at start-up, or during operation.

It is an object of the invention to address one or more of the foregoingproblems or at least provide the public with a useful choice.

BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devicesused in the diagnosis, amelioration, treatment, or prevention ofrespiratory disorders having one or more of improved comfort, cost,efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used inthe diagnosis, amelioration, treatment or prevention of a respiratorydisorder.

Another aspect of the present technology relates to methods used in thediagnosis, amelioration, treatment or prevention of a respiratorydisorder.

An aspect of the present technology is a medical humidification system.

An aspect of certain forms of the present technology is to provide arespiratory pressure treatment system comprising a medicalhumidification system which provides increased comfort to a patient. Anaspect of certain forms of the present technology is to provide methodsand/or apparatus that improve the compliance of patients withrespiratory therapy.

One form of the present technology provides an energy efficienthumidification system for medical use.

One aspect of the present technology is a humidification system formedical use which is less likely to give rise to condensation in an aircircuit.

One aspect of the present technology is a humidification system formedical use for a patient which provides a supply of air with waterdroplets to travel along an air circuit, and which vaporises the waterdroplets at an end of the air circuit close to the patient.

One aspect of the present technology is a humidification system formedical use comprising a nebuliser, an air circuit and a vaporiser.

An aspect of certain forms of the present technology is a medical devicethat is easy to use, e.g. by a person who does not have medicaltraining, by a person who has limited dexterity, vision or by a personwith limited experience in using this type of medical device.

An aspect of one form of the present technology is a portable RPT devicethat may be carried by a person, e.g., around the home of the person.

An aspect of one form of the present technology is a patient interfacethat may be washed in a home of a patient, e.g., in soapy water, withoutrequiring specialised cleaning equipment. An aspect of one form of thepresent technology is a humidifier tank that may be washed in a home ofa patient, e.g., in soapy water, without requiring specialised cleaningequipment.

According to one aspect of the present technology, there is provided anapparatus or system for treating a respiratory disorder in a patient.The apparatus may comprise a respiratory pressure therapy device. Therespiratory pressure therapy device may be configured to generate a flowof air for treating the respiratory disorder. The flow of air may be ata positive pressure with respect to ambient pressure.

The apparatus may further comprise an air circuit adapted to transportthe flow of air generated by the respiratory pressure therapy device toa patient interface. The air circuit may have a proximal end connectableto the respiratory pressure therapy device and a distal end connectableto the patient interface.

The apparatus may further comprise a nebuliser module located at oradjacent to the proximal end of the air circuit. The nebuliser modulemay be adapted to nebulise a liquid to form a nebula of the liquid. Thenebuliser may be further adapted to admit the nebula into the flow ofair generated by the respiratory pressure therapy device.

The apparatus may further comprise a vaporiser located at the distal endof the air circuit. The vaporiser may be adapted to receive the nebula.The vaporiser may be further adapted to vaporise the nebula to form ahumidified flow of air.

The apparatus may further comprise a patient interface adapted forreceiving the humidified flow of air and providing the humidified flowof air to the patient for treating the respiratory disorder.

The apparatus may further comprise a reservoir adapted to retain theliquid.

One form of the present technology provides a treatment system fortreating a respiratory disorder in a patient. The system may comprise arespiratory pressure therapy device configured to generate a flow of airat a positive pressure with respect to ambient pressure, an air circuitadapted to transport the flow of air to a patient interface, a waterreservoir configured to retain a volume of water for humidification ofthe flow of air, a nebuliser module adapted to receive water from thewater reservoir and to generate a nebula, and to admit the nebula intothe flow of air for delivery to a vaporiser module, and the vaporisermodule adapted to receive the nebula and comprising a heating elementconfigured to generate heat to vaporise the received nebula to humidifythe flow of air.

The vaporiser module may be directly connectable to the patientinterface.

The heating element may be formed of a thermally conductive materialcomprising one or more of a metal, a polymer, or a ceramic.

The vaporiser module may comprise a labyrinthine path therethrough forthe nebula and the flow of air.

The nebuliser module may be configured to admit the nebula into the flowof air parallel to the flow of air.

The nebuliser module may comprise the water reservoir.

The nebuliser module may comprise a nebuliser configured to float in thewater reservoir.

The nebuliser module may be located proximal to the respiratory pressuretherapy device.

The air circuit may be located between the nebuliser module and thevaporiser module.

The treatment system may further comprise a liquid filter locateddownstream of the vaporiser module and configured to block passage ofliquid water therethrough.

The air circuit may comprise a wire circuit to provide power andsignalling to the vaporiser module.

The air circuit may further comprise a hydrophobic coating on an innersurface thereof.

Another form of the present technology provides a nebuliser apparatusfor a respiratory treatment system, the respiratory treatment system fortreating a respiratory disorder in a patient. The nebuliser apparatusmay comprise an air inlet for receiving a flow of air at a positivepressure with respect to ambient pressure, a nebuliser configured toreceive a supply of water, generate a nebula from the supply of water,and admit the nebula into the flow of air. The nebuliser apparatus mayfurther comprise an outlet for the flow of air comprising the nebula,wherein the nebuliser module is configured to admit the nebula into theflow of air parallel to the flow of air.

The nebuliser apparatus may further comprise a water reservoirconfigured to retain a volume of water, the nebuliser being configuredto receive the supply of water from the water reservoir.

The nebuliser may be configured to float in the water reservoir.

Another form of the present technology provides a vaporiser apparatusfor a respiratory treatment system, the respiratory treatment system fortreating a respiratory disorder in a patient. The vaporiser apparatusmay comprise a vaporiser inlet for receiving a nebula in a flow of airat a positive pressure with respect to ambient pressure, a heatingelement configured to generate heat to vaporise the received nebula tohumify the flow of air, and a vaporiser outlet for the humidified flowof air. The vaporiser inlet and the vaporiser outlet may each beconfigured to be directly connectable to respective parts of an aircircuit.

Another form of the present technology provides a vaporiser apparatusfor a respiratory treatment system, the respiratory treatment system fortreating a respiratory disorder in a patient. The vaporiser apparatusmay comprise a vaporiser inlet for receiving a nebula in a flow of airat a positive pressure with respect to ambient pressure, a heatingelement configured to generate heat to vaporise the received nebula tohumidify the flow of air, and a vaporiser outlet for the humidified flowof air. The vaporiser apparatus may be configured to be directlyconnectable to a patient interface.

The heating element may be formed of a thermally conductive materialcomprising one or more of a metal, a polymer, or a ceramic.

The vaporiser apparatus may comprise a labyrinthine path therethroughfor the nebula and the flow of air.

The vaporiser apparatus may comprise one or more sensors adapted forsensing one or more parameters of the flow of air in the vaporiseroutlet, wherein the one or more parameters comprise one or more of:temperature; flow rate; pressure; and humidity of the flow of air in thevaporiser outlet.

The vaporiser apparatus may comprise a vent for venting a flow ofexhaled gases from a patient.

The vent may be positioned such that any water vapour in the flow ofexhaled gas from the patient is available for vaporising by the heatingelement for humidifying the flow of air before venting through the vent.

The vaporiser apparatus may comprise a vaporiser housing structured tomate, in use, with a supporting structure of the patient interface.

The vaporiser housing may comprise one or more connecting surfacessurrounding the vaporiser outlet, the one or more connecting surfacesbeing structured to mate, in use, with a supporting structure of thepatient interface.

Another form of the present technology provides a respiratory apparatusfor use in treating a respiratory disorder in a patient. The system maycomprise a vaporiser apparatus comprising a vaporiser inlet forreceiving a nebula in a flow of air at a positive pressure with respectto ambient pressure, a heating element configured to generate heat tovaporise the received nebula to humidify the flow of air, and avaporiser outlet for the humidified flow of air, and a patient interfacedirectly connected to the vaporiser apparatus.

The vaporiser apparatus may comprise a vaporiser housing and the patientinterface comprises a plenum chamber, wherein the vaporiser housing isconnected to the plenum chamber.

The vaporiser housing may comprise one or more connecting surfacessurrounding the vaporiser outlet, the one or more connecting surfacesbeing connected to a supporting structure of the plenum chamber.

The respiratory apparatus may comprise a vent for venting a flow ofexhaled gases from a patient.

The vent may be provided in the vaporiser housing.

An aspect of one form of the present technology is a method ofmanufacturing apparatus in any of the previous aspects.

The methods, systems, devices and apparatus described herein can provideimproved functioning in a processor, such as of a processor of aspecific purpose computer, respiratory monitor and/or a respiratorytherapy apparatus. Moreover, the described methods, systems, devices andapparatus can provide improvements in the technological field ofautomated management, monitoring and/or treatment of respiratoryconditions, including, for example, sleep disordered breathing.

Of course, portions of the aspects may form sub-aspects of the presenttechnology. Various ones of the sub-aspects and/or aspects may becombined in various manners and also constitute additional aspects orsub-aspects of the present technology.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,abstract, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

3.1 Treatment Systems

FIG. 1A shows a respiratory pressure treatment (RPT) system including apatient 1000 wearing a patient interface 3000, in the form of nasalpillows, receiving a supply of air at positive pressure from a RPTdevice 4000. Air from the RPT device 4000 is humidified in a humidifier5000 a, and passes along an air circuit 4170 to the patient 1000. A bedpartner 1100 is also shown. The patient 1000 is sleeping in a supinesleeping position.

FIG. 1B shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receiving a supply of airat positive pressure from a RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000 a, and passes along an air circuit 4170to the patient 1000.

FIG. 1C shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receiving a supply ofair at positive pressure from a RPT device 4000. Air from the RPT deviceis humidified in a humidifier 5000 a, and passes along an air circuit4170 to the patient 1000. The patient 1000 is sleeping in a sidesleeping position.

3.2 Respiratory System and Facial Anatomy

FIG. 2 shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

3.3 Patient Interface

FIG. 3 shows a patient interface in the form of a nasal mask inaccordance with one form of the present technology.

3.4 RPT Device

FIG. 4A shows a RPT device in accordance with one form of the presenttechnology.

FIG. 4B is a schematic diagram of the pneumatic path of a RPT device inaccordance with one form of the present technology. The directions ofupstream and downstream are indicated.

FIG. 4C is a schematic diagram of the electrical components of a RPTdevice in accordance with one form of the present technology.

FIG. 4D is a schematic diagram of the algorithms implemented in a RPTdevice in accordance with one form of the present technology.

FIG. 4E shows a model typical breath waveform of a person whilesleeping.

FIG. 4F shows the components of an example RPT system for treatment of asleep disordered breathing condition in accordance with one form of theprior art.

FIG. 4G is a schematic illustration of a RPT system incorporating anebulising humidification system according to one form of the presenttechnology.

3.5 Humidifier

FIG. 5A shows an isometric view of a RPT system in accordance with oneform of the present technology.

FIG. 5B shows a schematic of the electrical components of part of a RPTsystem in accordance with one form of the present technology.

FIG. 6 shows a schematic view of a RPT system comprising a nebulisinghumidifier according to one form of the present technology;

FIG. 7A shows a part of a RPT system connected to a nebuliser module5100 according to one form of the present technology;

FIG. 7B shows an exploded view of the water reservoir 5110 of thenebuliser module 5100 according to one form of the present technology;

FIG. 7C shows an exploded view of a nebuliser module housing accordingto one form of the present technology;

FIGS. 7D and 7E respectively show example arrangements of a nebulisermodule 5100 according to one form of the present technology;

FIG. 7F shows an example of a nebuliser module 5100 according to certainforms of the present technology;

FIG. 7G shows a cross-sectional view of a nebuliser module 5100 alongthe dashed line of FIG. 7F;

FIGS. 8A and 8B are illustrations of a vaporiser module 5500 accordingto certain forms of the present technology;

FIGS. 8C and 8D show examples of an exemplary vaporiser module 5500 asdisclosed herein attached to a patient interface, respectively apillows-type patient interface 3001 and a full-face-type patientinterface 3003 according to certain forms of the present technology;

FIG. 8E shows a schematic cross-sectional view of vaporiser module 5500along line A-A of FIG. 8B;

FIG. 8F shows a schematic cross-sectional view of an alternatearrangement of a vaporiser module 5500 according to one form of thepresent technology;

FIGS. 9A and 9B shows example arrangements of an in-line vaporisermodule 5500 according to certain forms of the present technology.

DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

The following description is provided in relation to various exampleswhich may share one or more common characteristics and/or features. Itis to be understood that one or more features of any one example may becombinable with one or more features of another example or otherexamples. In addition, any single feature or combination of features inany of the examples may constitute a further example.

4.1 Therapy

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

In certain examples of the present technology, a supply of air atpositive pressure is provided to the nasal passages of the patient viaone or both nares.

In certain examples of the present technology, mouth breathing islimited, restricted or prevented.

4.2 Treatment Systems

In one form, the present technology comprises an apparatus or device fortreating a respiratory disorder. The apparatus or device may comprise anRPT device 4000 for supplying pressurised air to the patient 1000 via anair circuit 4170 to a patient interface 3000.

4.3 Patient Interface

A non-invasive patient interface 3000 in accordance with one aspect ofthe present technology is shown in FIG. 3 and comprises the followingfunctional aspects: a seal-forming structure 3100, a plenum chamber3200, a positioning and stabilising structure 3300 (headgear), a vent3400, one form of connection port 3600 for connection to air circuit4170, and a forehead support 3700. In some forms a functional aspect maybe provided by one or more physical components. In some forms, onephysical component may provide one or more functional aspects. In use,the seal-forming structure 3100 is arranged to surround an entrance tothe airways of the patient so as to facilitate the supply of air atpositive pressure to the airways. The patient interface 3000 maycomprise an anti-asphyxia valve.

If a patient interface is unable to comfortably deliver a minimum levelof positive pressure to the airways, the patient interface may beunsuitable for respiratory pressure therapy.

The patient interface 3000 in accordance with some forms of the presenttechnology is constructed and arranged to be able to provide a supply ofair at a positive pressure of at least 6 cmH₂O, at least 10 cmH₂O or atleast 20 cmH₂O with respect to ambient.

4.3.1 Plenum Chamber

The plenum chamber 3200 has a perimeter that is shaped to becomplementary to the surface contour of the face of an average person inthe region where a seal will form in use. In use, a marginal edge of theplenum chamber 3200 is positioned in close proximity to an adjacentsurface of the face. Actual contact with the face is provided by theseal-forming structure 3100. The seal-forming structure 3100 may extendin use about the entire perimeter of the plenum chamber 3200. In someforms, the plenum chamber 3200 and the seal-forming structure 3100 areformed from a single homogeneous piece of material.

In certain forms of the present technology, the plenum chamber 3200 doesnot cover the eyes of the patient in use. In other words, the eyes areoutside the pressurised volume defined by the plenum chamber. Such formstend to be less obtrusive and/or more comfortable for the wearer, whichcan improve compliance with therapy.

4.3.2 Vent

In one form, respiratory therapy system includes a vent 3400 constructedand arranged to allow for the washout of exhaled gases, e.g. carbondioxide. In some forms, the patient interface 3000 may comprise the vent3400. In other forms, the vent 3400 may be located elsewhere in therespiratory therapy system in addition to, or instead of, the patientinterface 3000. For example, the respiratory therapy system may includea vent module located between the patient interface 3000 and the RPTdevice 4000, the vent module comprising a vent 3400.

In certain forms the vent 3400 is configured to allow a continuous ventflow from an interior of the plenum chamber 3200 to ambient whilst thepressure within the plenum chamber 3200 is positive with respect toambient. The vent 3400 is configured such that the vent flow rate has amagnitude sufficient to reduce rebreathing of exhaled CO2 by the patientwhile maintaining the therapeutic pressure in the plenum chamber in use.

One form of vent 3400 in accordance with the present technologycomprises a plurality of holes, for example, about 20 to about 80 holes,or about 40 to about 60 holes, or about 45 to about 55 holes.

The vent 3400 may be located in the plenum chamber 3200. Alternatively,the vent 3400 is located in a decoupling structure, e.g., a swivel.

4.3.3 Connection Port

Connection port 3600 of the patient interface 3000 allows for connectionto the air circuit 4170.

4.4 RPT Device

An RPT device 4000 in accordance with one aspect of the presenttechnology comprises mechanical, pneumatic, and/or electrical componentsand is configured to execute one or more algorithms 4300. The RPT device4000 may be configured to generate a flow of air for delivery to apatient's airways, such as to treat one or more of the respiratoryconditions described elsewhere in the present document.

In one form, the RPT device 4000 is constructed and arranged to becapable of delivering a flow of air in a range of −20 L/min to +150L/min while maintaining a positive pressure of at least 6 cmH₂O, or atleast 10cmH₂O, or at least 20 cmH₂O for respiratory therapy.

As seen in FIG. 4A, the RPT device 4000 may have an external housing4010, formed in two parts, an upper portion 4012 and a lower portion4014. Furthermore, the external housing 4010 may include one or morepanel(s) 4015. The RPT device 4000 comprises a chassis 4016 thatsupports one or more internal components of the RPT device 4000. The RPTdevice 4000 may include a handle 4018.

The pneumatic path of the RPT device 4000, as seen in FIG. 4B, maycomprise one or more air path items, e.g., an inlet air filter 4112, aninlet muffler 4122, a pressure generator 4140 capable of supplying airat positive pressure (e.g., a blower 4142), an outlet muffler 4124 andone or more transducers 4270, such as pressure sensors 4272 and flowrate sensors 4274.

The RPT device 4000 may have an electrical power supply 4210, one ormore input devices 4220, a central controller 4230, a therapy devicecontroller 4240, a pressure generator 4140, one or more protectioncircuits 4250, memory 4260, transducers 4270, data communicationinterface 4280 and one or more output devices 4290. Electricalcomponents 4200 may be mounted on a single Printed Circuit BoardAssembly (PCBA) 4202. In an alternative form, the RPT device 4000 mayinclude more than one PCBA 4202.

4.4.1 RPT Device Mechanical & Pneumatic Components

An RPT device 4000 may comprise one or more of the following componentsin an integral unit, for example as seen in FIGS. 4B and 4C. Inalternative forms, one or more of the following components may belocated as respective separate units.

4.4.1.1 Pressure Generator

In one form of the present technology, a pressure generator 4140 forproducing a flow, or a supply, of air at positive pressure is acontrollable blower 4142. The blower may be capable of delivering asupply of air, for example at a rate of up to about 120 litres/minute,at a positive pressure in a range from about 4 cmH₂O to about 20 cmH₂O,or in other forms up to about 30 cmH₂O. The blower may be as describedin any one of the following patents or patent applications the contentsof which are incorporated herein by reference in their entirety: U.S.Pat. Nos. 7,866,944; 8,638,014; 8,636,479; and PCT Patent ApplicationPublication No. WO 2013/020167.

4.4.1.2 Transducer(s)

Transducers 4270 may be internal of the RPT device 4000, or external ofthe RPT device 4000. External transducers may be located for example onor form part of the air circuit 4170, e.g., the patient interface 3000.External transducers may be in the form of non-contact sensors such as aDoppler radar movement sensor that transmit or transfer data to the RPTdevice 4000.

In one form of the present technology, one or more transducers 4270 arelocated upstream and/or downstream of the pressure generator 4140. Theone or more transducers 4270 may be constructed and arranged to generatesignals representing properties of the flow of air such as a flow rate,a pressure or a temperature at that point in the pneumatic path.

In one form of the present technology, one or more transducers 4270 maybe located proximate to the patient interface 3000.

In one form, a signal from a transducer 4270 may be filtered, such as bylow-pass, high-pass or band-pass filtering.

4.4.1.2.1 Flow Rate Sensor

A flow rate sensor 4274 in accordance with the present technology may bebased on a differential pressure transducer, for example, an SDP600Series differential pressure transducer from SENSIRION.

In one form, a signal representing a flow rate from the flow rate sensor4274 is received by the central controller 4230.

4.4.1.2.2 Pressure Sensor

A pressure sensor 4272 in accordance with the present technology islocated in fluid communication with the pneumatic path. An example of asuitable pressure sensor is a transducer from the HONEYWELL ASDX series.An alternative suitable pressure sensor is a transducer from the NPASeries from GENERAL ELECTRIC.

In one form, a signal from the pressure sensor 4272 is received by thecentral controller 4230.

4.4.2 RPT Device Electrical Components 4.4.2.1 Power Supply

A power supply 4210 may be located internal or external of the externalhousing 4010 of the RPT device 4000.

In one form of the present technology, power supply 4210 provideselectrical power to the RPT device 4000 only. In another form of thepresent technology, power supply 4210 provides electrical power to bothRPT device 4000 and humidifier system 5000.

4.4.2.2 Input Devices

In one form of the present technology, an RPT device 4000 includes oneor more input devices 4220 in the form of buttons, switches or dials toallow a person to interact with the device. The buttons, switches ordials may be physical devices, or software devices accessible via atouch screen. The buttons, switches or dials may, in one form, bephysically connected to the external housing 4010, or may, in anotherform, be in wireless communication with a receiver that is in electricalconnection to the central controller 4230.

4.4.2.3 Central Controller

In one form of the present technology, the central controller 4230 isone or a plurality of processors suitable to control an RPT device 4000.

Suitable processors may include an x86 INTEL processor, a processorbased on ARM® Cortex®-M processor from ARM Holdings such as an STM32series microcontroller from ST MICROELECTRONIC. In certain alternativeforms of the present technology, a 32-bit RISC CPU, such as an STR9series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPUsuch as a processor from the MSP430 family of microcontrollers,manufactured by TEXAS INSTRUMENTS may also be suitable.

In various forms of the present technology, the central controller 4230may comprise one or more of a dedicated electronic circuit, anapplication-specific integrated circuit, and discrete electroniccomponents.

The central controller 4230 may be configured to receive input signal(s)from one or more transducers 4270, one or more input devices 4220, andthe humidifier system 5000.

The central controller 4230 may be configured to provide outputsignal(s) to one or more of an output device 4290, a therapy devicecontroller 4240, a data communication interface 4280, and the humidifiersystem 5000.

In some forms of the present technology, the central controller 4230 isconfigured to implement the one or more methodologies described herein,such as the one or more algorithms 4300 expressed as computer programsstored in a non-transitory computer readable storage medium, such asmemory 4260. In some forms of the present technology, the centralcontroller 4230 may be integrated with an RPT device 4000. However, insome forms of the present technology, some methodologies may beperformed by a remotely located device. For example, the remotelylocated device may determine control settings for a ventilator or detectrespiratory related events by analysis of stored data such as from anyof the sensors described herein.

4.4.2.4 Therapy Device Controller

In one form of the present technology, therapy device controller 4240 isa therapy control module 4330 that forms part of the algorithms 4300executed by the central controller 4230.

4.4.2.5 Protection Circuits

The one or more protection circuits 4250 in accordance with the presenttechnology may comprise an electrical protection circuit, a temperatureand/or pressure safety circuit.

4.4.2.6 Memory

In accordance with one form of the present technology the RPT device4000 includes memory 4260, e.g., non-volatile memory. In some forms,memory 4260 may include battery powered static RAM. In some forms,memory 4260 may include volatile RAM.

Memory 4260 may be located on the PCBA 4202. Memory 4260 may be in theform of EEPROM, or NAND flash.

In one form of the present technology, the memory 4260 acts as anon-transitory computer readable storage medium on which is storedcomputer program instructions expressing the one or more methodologiesdescribed herein, such as the one or more algorithms 4300.

4.4.3 RPT Device Algorithms

As mentioned above, in some forms of the present technology, the centralcontroller 4230 may be configured to implement one or more algorithms4300 expressed as computer programs stored in a non-transitory computerreadable storage medium, such as memory 4260.

4.5 Humidifier System 4.5.1 Humidifier Overview

In one form of the present technology there is provided a humidifiersystem 5000. One purpose of a humidifier system 5000 is to change theabsolute humidity and/or temperature of air or gas for delivery to apatient relative to ambient air. Typically, the humidifier system 5000is used to increase the absolute humidity and increase the temperatureof the flow of air (relative to ambient air) before delivery to thepatient's airways.

FIGS. 1A-1C and 4F shows a schematic overview of the components of anexample RPT system for treatment of a sleep disordered breathingcondition comprising a RPT device 4000 for generating a flow ofbreathable air and a humidifier 5000 a adapted to receive the flow ofbreathable air from the RPT device 4000 and output a flow of humidifiedbreathable air to an air circuit 4170, whereupon the humidified airpasses along the air circuit 4170 to a patient interface 3000 to bebreathed by a patient 1000.

There are a plurality of available humidifier configurations.

Humidifier system 5000 may comprise a humidifier 5000 a configured tochange the absolute humidity of air or gas for delivery to a patientrelative to ambient air. Additionally, or alternatively, a humidifiersystem 5000 may comprise one or more other components configured tochange the temperature and/or the absolute humidity of air or gas fordelivery to a patient relative to ambient air as described in relationto the following examples.

FIG. 4G is a schematic illustration of a RPT system according to anexample of the present technology and FIG. 5A shows an isometric view ofthe RPT system according to an example of the technology.

According to one aspect of the present technology, a humidifier system5000 may comprise a nebuliser module 5100, configured to generate anddeliver a nebula 5300 to an air circuit 4170 for delivery to a vaporisermodule 5500 configured to evaporate the nebula 5300 to humidify a flowof air for delivery to a patient. The humidifier system 5000 may furthercomprise one or more of: a set of transducers, a heat-moistureexchanger, a vent and a controller.

As will be described, particular arrangements of humidification system5000 in some forms of the technology may additionally comprise a filter5600 adapted to be impermeable to liquid water (H₂O) but permeable tobreathable gases generated by RPT device 4000 and also permeable towater vapour formed in vaporiser module 5500.

4.5.2 Humidifier Components

One or more components of a humidifier system may be modular; that is,removable from the rest of the humidifier system, for reasons such as,but not limited to, cleaning, repairs, replacement, or upgrade. However,in some forms, components (e.g. nebuliser module or vaporiser module)may not be removable from another component. In the present document,‘module’ may be read as a ‘subsystem’ or ‘component’ rather than to belimited to arrangements of physical modularity.

4.5.2.1 Nebuliser Module

In one form, a nebuliser module 5100 comprises a water reservoir 5110, anebuliser air inlet 5002 to receive a flow of air from a RPT device4000, and a nebuliser outlet 5004 to deliver a flow of air comprising afine mist (or nebula) of liquid (typically water).

4.5.2.1.1 Water Reservoir

According to one arrangement, the humidifier system 5000 may comprise awater reservoir 5110 configured to hold, or retain, a volume of liquid(e.g. water) to be evaporated for humidification of the flow of air. Thewater reservoir 5110 may be configured to hold a predetermined maximumvolume of water in order to provide adequate humidification for at leastthe duration of a respiratory therapy session, such as one evening ofsleep. Typically, the reservoir 5110 is configured to hold severalhundred millilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 mlor 400 ml. In other forms, the humidifier system 5000 may be configuredto receive a supply of water from an external water source such as abuilding's water supply system.

According to one aspect as disclosed herein, the water reservoir 5110 isconfigured to store and/or provide liquid water to be added to a flow ofair from the RPT device 4000 as the flow of air travels through thenebulising module 5100.

According to one form, the water reservoir 5110 may be removable fromthe remainder of the nebulising module 5100, for example, for filling ofthe reservoir. Alternatively, or additionally, the reservoir 5110 maycomprise a lid 5112 which can be readily opened to facilitate filling ofthe reservoir 5110 with a suitable liquid such as, for example, water,through an opening without removing reservoir 5110 from the remainder ofthe nebuliser module 5100. In some forms of the technology the reservoir5110 may have no lid or cover over the opening.

4.5.2.1.2 Nebuliser

The nebuliser module 5100 may comprise a nebuliser 5120 as shownschematically in FIG. 6 .

The nebuliser module 5100 nebulises liquid from a water reservoir 5110in order for the nebula 5300 to be admitted into the air path 5200 ofthe breathable air generated by RPT device 4000. The nebuliser maygenerate a nebula 5300 of liquid, the nebula 5300 comprising a particlesize distribution suitable for transport by the flow of air for deliveryto a vaporiser module. The nebuliser module 5100 may in some formsdirectly introduce the nebula 5300 into the air path. In some forms thenebuliser module may be configured to introduce the nebula 5300 in aparallel direction to the flow of air through the air path. In someforms, the nebuliser module may be configured to introduce the nebula5300 in a perpendicular direction to the flow of air through the airpath. It is recognised that in some forms the nebula is introduced tothe flow of air in a way in which not all the liquid particles have thesame direction of motion. In such cases the direction of introduction ofthe nebula may be understood to mean the direction of the averagevelocity vector of the liquid particles when they are introduced.

In some forms, the nebuliser 5120 may be configured to directlyintroduce nebula 5300 into the air path, for example the nebuliser 5120may form part of the wall of the air path, for example by being locatedin an opening in the wall of the air path. In some forms, the nebula5300 may be introduced into the air path via one or more additionalcomponents, for example the nebuliser 5120 may form part of the body ofthe water reservoir and connect to the air path via a nebuliser conduitor injection valve.

In particular arrangements, a nebuliser 5120 may include an apertureplate or a mesh positioned between the reservoir 5110 and the air path5200, for example in an opening in a wall between the reservoir 5110 andthe air path 5200, with one or more small holes (e.g., average of ˜2 μm)that is connected to a vibrational element such as for example, apiezoelectric transducer or an ultrasonic horn driven by a piezoelectricelement. Vibration of the vibrational element causes the mesh oraperture plate to vibrate, which causes liquid to move from thereservoir 5110 through the holes and into an air path 5200, convertingthe liquid to aerosolised particles (i.e., nebulising the liquid). Inparticular arrangements, the vibrational element may include apiezoelectric element. In particular arrangements, the piezoelectricelement may comprise the aperture plate having the one or more holes. Insome arrangements, the transducer may be indirectly connected to themesh or aperture plate via one or more vibration transmission elements,for example in the form of a rod, which the vibrational element willvibrate and in turn causes the mesh or aperture plate to vibrate. Inparticular arrangements, nebuliser 5120 may include a pressure-basednebuliser that creates a pressure which forces liquid through one ormore orifices so as to nebuliser the liquid in the reservoir 5110 andpropel it into the air path 5200. It will be understood that any numberof other known mechanisms to generate a nebula 5300 may be employed fora nebuliser 5120.

FIG. 7A shows a RPT device 4000 connected to a nebuliser module 5100according to one form of the technology. Nebuliser housing 5130 may alsocomprise an inlet connection port 5135, adapted for pneumatic and/orelectrical connection to RPT device 4000; outlet connection port 5140,adapted for both pneumatic and/or electrical connection to air circuit4170; and air path 5200 between inlet connection port 5135 and outletconnection port 5140, wherein air path 5200 is in fluidic communicationwith reservoir 5110 via nebuliser 5120.

FIG. 7B shows an exploded view of reservoir 5110 comprising a lid 5112and opening 5113 according to one form of the technology. In thearrangement, opening 5113 is adapted to receive nebuliser retainingcollar 5115 and nebuliser 5120 such that nebuliser 5120 is integratedwith reservoir 5110. In other arrangements, nebuliser 5120 may insteadbe integrated with nebuliser housing 5130. In this alternatearrangement, a replacement reservoir 5110 does not also need toincorporate the nebuliser 5120 hence beneficially making replacementreservoirs more cost effective.

FIG. 7C shows an exploded view of the nebuliser housing 5130 shown inFIG. 7A. The nebuliser housing 5130 comprises a frame 5131; a nebuliseractivator unit 5121 comprising a vibrational element such as forexample, a piezoelectric transducer; an inlet connection port 5135; anoutlet connection port 5140; a nebuliser control circuitry 5150comprising nebuliser controller 5240; and a housing cover 5137.

In the form of the technology illustrated in FIGS. 7A, 7B and 7C,reservoir 5110 is positioned above nebuliser housing 5130, through whichair path 5200 passes. Nebuliser 5120 is positioned in or below anopening 5113 in the bottom of reservoir 5110 and liquid in reservoir5110 is fed to the nebuliser 5120 under gravity. In other forms of thetechnology, the reservoir 5110 may be positioned horizontally adjacentto or below nebuliser housing 5130, through which air path 5200 passes.In one form, the walls of reservoir 5110 form part of the walls ofnebuliser housing 5130.

FIGS. 7D and 7E show two alternate arrangements of a nebuliser module5100 in other forms of the present technology, each including areservoir 5110 for retaining liquid 5111, the reservoir being in fluidcommunication with air path 5200 via nebuliser 5120. In the forms of thetechnology shown in both figures the air path 5200 passes beneath thereservoir 5110 and the bottom wall of the reservoir 5110 is shared withor positioned adjacent to the upper wall defining the air path 5200.

In FIG. 7D air path 5200 passes linearly and horizontally throughnebuliser housing 5130. Nebula 5300 injected into air path 5200 ispicked up and carried along air circuit 4170 to vaporiser module 5500(not shown) located at the distal end of air circuit 4170. In thisarrangement, air flow must be fast enough such that nebula 5300 isentrained in the air flow so that the nebula 5300 may be delivered tothe vaporiser module 5500 before it hits the bottom of air path 5200. Ifthe nebula 5300 is not picked up, then nebula 5300 will accumulate aswater in air path 5200 in addition to not reaching the vaporiser module5500 for humidification. In FIG. 7E, air path 5200 includes a verticallyoriented portion 5122 fluidly connected between two horizontallyoriented portions 5123, the vertically oriented portion 5122 positioneddirectly beneath nebuliser 5120 such that nebula 5300 has a verticaldistance to fall before impacting the bottom wall of air path 5200.Accordingly, the nebula 5300 has a greater chance of matching thevelocity of the air flow from RPT device 4000 and thus being picked upand carried by the air flow along air circuit 4170 to vaporiser module5500 located at the distal end of air circuit 4170. In other forms ofthe technology the air path 5200 may comprise a sloped portionpositioned substantially below the nebuliser.

In another form the nebuliser 5120 comprises a floating element. Thefloating element floats in the liquid 5111 in the reservoir 5110. Thefloating element is configured such that at least part of its uppersurface is exposed above the level of the liquid. In this arrangement,the nebuliser module is configured such that the air path 5200 passesacross the top of the liquid 5111 in the reservoir 5110 and the top ofthe floating element is exposed to the air path 5200. The floatingelement may take any number of forms. In one example the floatingelement is torus-shaped.

FIGS. 7F and 7G are illustrations of a nebuliser module 5100 accordingto certain forms of the present technology. FIG. 7G shows across-sectional view along the dashed line in FIG. 7F. Nebuliser module5100 comprises nebuliser housing 5130, a water reservoir 5110 with a lid5112, as well as a nebuliser inlet 5002 for receiving a pressurised flowof air and a nebuliser outlet 5004 for delivering a flow of aircontaining a nebula 5300 of liquid water to another part of the RPTdevice 4000, for example air circuit 4170. Air path 5200 fluidlyconnects nebuliser inlet 5002 and nebuliser outlet 5004. The nebulisermodule 5100 is arranged with the water reservoir 5110 positioned aboveair path 5200 so that there is a head of water to deliver water intonebuliser 5120 when the nebuliser valve 5125 is open.

Nebuliser module 5100 further comprises an electrical plug 5180, whichmay be in a bottom portion of a side wall of the nebuliser module 5100.In the embodiment shown the electrical plug 5180 is positioned in thesame side wall as, and below, the nebuliser inlet 5002. Electrical plugmay be configured to connect to the electrical components 4200 of theRPT device 4000. Nebuliser module 5100 also comprises an electricalsocket 5170 for connecting the nebuliser control circuitry 5150 to thewire circuits 4171 of the air circuit 4170 which provide power andsignalling to vaporiser module 5500. The electrical socket 5170 may bein a bottom portion of a side wall of the nebuliser module 5100. In theembodiment shown the electrical socket 5170 is positioned in the sameside wall as, and below, the nebuliser outlet 5004. As shown in FIG. 7F,nebuliser module 5100 comprises an outlet connection port 5140 forconnection to air circuit 4170.

FIG. 7G shows a nebuliser 5120 which is connected to water reservoir5110 via a nebuliser valve 5125 and nebuliser valve seat 5126. Nebuliservalve 5125 is positioned in the bottom wall of the water reservoir 5110and is adapted to control the flow of water from the reservoir to thenebuliser 5120. In the embodiment shown nebuliser 5120 is positionedbelow nebuliser valve 5125 and water admitted through the nebuliservalve 5125 is delivered to the nebuliser 5120 under gravity. Nebulainlet 5190 is positioned below nebuliser 5120 and delivers the nebula5300 to the air path 5200. Nebula inlet 5190 may be provided in a wallof the air path 5200, for example the top wall as shown in FIG. 7G. Thearrangement of the nebuliser 5120 and nebula inlet 5190 allows thenebula to be introduced into the air path 5200 in a direction(vertically downwards as shown in FIG. 7G) that is perpendicular to thedirection of the flow of air through the air path (horizontally to theright as shown in FIG. 7G).

4.5.2.1.3 Water Level Indicator

The water reservoir 5110 may comprise a water level indicator 5160. Insome forms, the water level indicator may provide one or moreindications to a user such as the patient 1000 or a care giver regardinga quantity of the volume of water in the reservoir 5110. The one or moreindications provided by the water level indicator may include anindication of a maximum, predetermined volume of water, any portionsthereof, such as 25%, 50% or 75% or volumes such as 200 ml, 300 ml or400 ml.

4.5.2.2 Humidifier Transducer(s)

The humidifier system 5000 may comprise one or more humidifiertransducers (sensors) 5210 instead of, or in addition to, transducers4270 described above. Humidifier transducers 5210 may include one ormore of an air pressure sensor 5212, an air flow rate transducer 5214, atemperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5B.A humidifier transducer 5210 may produce one or more output signalswhich may be communicated to a controller such as the central controller4230 and/or the humidifier controller 5250. In some forms, a humidifiertransducer may be located externally to the humidifier system 5000 (suchas in the air circuit 4170) while communicating the output signal to thecontroller.

4.5.2.2.1 Pressure Transducer

One or more air pressure transducers 5212 may be provided to thehumidifier system 5000 in addition to, or instead of, a pressure sensor4272 provided in the RPT device 4000.

4.5.2.2.2 Flow Rate Transducer

One or more air flow rate transducers 5214 may be provided to thehumidifier system 5000 in addition to, or instead of, a flow rate sensor4274 provided in the RPT device 4000.

4.5.2.2.3 Temperature Transducer

The humidifier system 5000 may comprise one or more temperaturetransducers 5216. The one or more temperature transducers 5216 may beconfigured to measure one or more temperatures such as of the heatingelement 5530 and/or of the flow of air downstream of the humidifieroutlet 5004. In some forms, the humidifier system 5000 may furthercomprise a temperature sensor 5216 to detect the temperature of theambient air.

4.5.2.2.4 Humidity Transducer

In one form, the humidifier system 5000 may comprise one or morehumidity sensors 5218 to detect a humidity of a gas, such as the ambientair. The humidity sensor 5218 may be placed towards the humidifieroutlet 5004 in some forms to measure a humidity of the gas deliveredfrom the humidifier system 5000. The humidity sensor 5218 may be anabsolute humidity sensor or a relative humidity sensor.

4.5.2.3 Nebuliser Controller

According to one arrangement of the present technology, humidifiersystem 5000 may comprise a nebuliser controller 5240, such as shown inFIG. 5B. In one form, the nebuliser controller 5240 forms part ofhumidifier controller 5250 and, in particular arrangements, may be apart of the central controller 4230. In another form, the nebulisercontroller 5240 and the humidifier controller 5250 may each be aseparate controller, which may be in communication with the centralcontroller 4230. In some forms, the nebuliser module 5100 may comprisethe nebuliser controller 5240 which may be electrically connected tohumidifier controller 5250 and/or to the central controller 4230 of RPTdevice 4000 by electrical connections (not shown). Nebuliser housing5130 in some forms may house a nebuliser controller 5240. In other formsthe nebuliser controller 5240 may be located in the RPT device 4000.

In one form, the humidifier controller 5250 and/or the nebulisercontroller 5240 may receive as inputs measures of properties (such astemperature, humidity, pressure and/or flow rate), for example of theflow of air, the water in the reservoir 5110. The nebuliser controller5240 may also be configured to execute or implement humidifieralgorithms and/or deliver one or more output signals. The nebulisercontroller 5240 may be configured to reduce or increase the nebulisationrate based on the detection of the presence or absence of an optionalheat and moisture exchange (HMX) module 5510. The nebuliser controller5240 may also be configured to increase or decrease the nebulisationrate based on accumulation (nebulised water droplets that are trapped inthe air circuit 4170), which can be estimated or detected by comparingthe nebulisation rate against absolute humidity calculated from aRelative Humidity and Temperature (RHT) sensor. The RHT sensor may senda feedback signal 5230 to the vaporiser controller 5252 which may thensend a heater control signal 5231 to the heating element 5530.

As shown in FIG. 5B, the humidifier controller 5250 may comprise one ormore other controllers, such as a central humidifier controller 5251and/or a vaporiser controller 5252 configured to control electroniccomponents included in vaporiser module 5500 including, but not limitedto, the temperature of a heating element 5530 and temperature, pressure,flow rate and/or humidity sensors located in vaporiser module 5500.

4.5.2.4 Air Circuit

In one form of the present technology an air circuit 4170 suitable foruse in nebulising humidification system 5000 comprises a flexibleconduit or a tube constructed and arranged to allow, in use, a flow ofair to travel between two components such as RPT device 4000 and thepatient interface 3000.

In particular, the air circuit 4170 may be in fluid connection with theoutlet of the pneumatic block 4020 and the patient interface 3000. Theair circuit 4170 may be referred to as an air delivery tube. In somecases, there may be separate limbs of the circuit for inhalation andexhalation. In other cases, a single limb is used.

In some forms, the air circuit 4170 may comprise one or more wirecircuits configured to provide power and/or signalling between RPTdevice 4000 and electrical components included at the distal end of aircircuit 4170 (i.e. proximal to patient interface 3000), for examplecontrol circuitry for vaporiser module 5500 and/or transducers providedin vaporiser module 5500 and/or patient interface 3000 such as, forexample pressure, flow rate, temperature, and/or humidity sensors. Theone or more wire circuits may comprise one or more transducers, such astemperature sensors. In one form, the wire circuit is located on theinterior of the air circuit 4170, for example attached to the inner wallof the airflow conduit or floating independently within the conduit. Inanother form, the wire circuit is located on the exterior of the aircircuit 4170, for example an external conduit could be aligned parallelto the axis of the fluid conduit or the wire circuit may be helicallywound around the axis of the air circuit 4170. The airflow conduit maycomprise more than one independent helical rib or conduit with, and/oranother rib configured to include one or more electrical wires for datacommunications, and/or another rib configured to include electricalwires that may be used for heating of the airflow conduit, although thismay not be necessary when using a nebuliser.

In particular arrangements, air circuit 4170 may comprise a hydrophobiccoating on an inner surface of the conduit to minimise liquidaccumulation on the inner wall of the air circuit 4170.

4.5.2.5 Vaporiser Module

A vaporiser module 5500 may be configured to receive the nebula 5300from the nebuliser module 5100, and to evaporate the nebula 5300 tohumidify the flow of air for delivery to the patient. The vaporisermodule 5500 may be located proximal to the patient, such that thehumidified air is not required to travel as far to reach the patient,thus reducing a risk of condensation en route to the patient. Thepatient interface 3000 may comprise at least a part of the vaporisermodule 5500, such as in forms shown in FIGS. 8C and 8D, or the vaporisermodule 5500 may be located on a separate component, such as togetherwith the vent module 3410. In particular arrangements, vaporiser module5500 comprises a vaporiser inlet 3250 configured for receiving a nebula5300 in a flow of air from air circuit 4170 to which the vaporiser inlet3250 is fluidly connected in use.

It will be understood that the vaporiser module is configured to cause achange in phase of liquid water in nebula 5300 to water vapour. In someforms of the technology the vaporiser module may achieve this phasechange through boiling the liquid water in nebula 5300. In other forms,the liquid water in nebula 5300 may evaporate. Unless clearly indicatedotherwise it will be understood that the term “vaporise” is intended toencompass both boiling and evaporation.

In particular arrangements, vaporiser module 5500 comprises one or moreheating elements 5530. The heating element 5530 may be in communicationwith a controller such as a central humidifier controller 5251,nebuliser controller 5240, and/or vaporiser controller 5252. Vaporisermodule 5500 optionally may comprise sensors 5210 including pressure,airflow, temperature and/or humidity sensors which can provide feedbackinput to humidifier controller 5250, nebuliser controller 5240 and/orvaporiser controller 5252 to enable control algorithms to controlhumidifier system 5000 to provide the desired temperature, humidity andpositive pressure to the patient interface 3000.

Heating element 5530 and sensors 5210 may be controlled by vaporisercontroller 5252 to provide sufficient heating to provide a humidifiedflow of air to the patient interface having the desired temperature,pressure and humidity characteristics for effective RPT treatment ofpatient 1000. A Printed Circuit Board (PCB) 5540 may be located in thevaporiser module 5500. PCB 5540 may comprise various electricalcomponents which form part of vaporiser controller 5252.

In particular arrangements, the vaporiser module 5500 may also comprisean optional heat and moisture exchange (HMX) module 5510. One example ofan HMX module 5510 is described in United States Patent ApplicationPublication No. 2016/0175552, which is incorporated herein in byreference its entirety. The HMX module 5510 may be positioned downstream(i.e. patient side) of the vaporiser module 5500 in the RPT system.

In some configurations, the vaporiser module 5500 may be configured toreceive a supply of water for humidifying the flow of air in addition tothe supply of water from the nebuliser. For example, the vaporisermodule may be configured to receive liquid water pumped through a flowconduit to the heating element. The flow conduit may be located eitherwithin the air circuit 4170 or external to the air circuit 4170.

FIGS. 8A and 8B are illustrations of a vaporiser module 5500 accordingto certain forms of the present technology. FIGS. 8C and 8D areillustrations of a vaporiser module 5500 provided to a patient interface3000 according to different forms of the present technology. FIGS. 8Eand 8F are cross-sectional views of vaporiser module 5500 attached topart of an air circuit 4170 according to different forms of the presenttechnology.

In some forms of the technology, the patient interface 3000 may bedirectly connectable to the vaporiser module 5500. The patient interface3000 may comprise a supporting structure to hold a vaporiser module 5500in position, wherein the supporting structure may comprise one or moresurfaces surrounding an opening in the plenum chamber 3200. In the formsof patient interface 3000 shown in FIGS. 8C and 8D the opening in theplenum chamber 3200 is on an anterior side of the patient interfaceduring use. The opening is shaped and structured to substantially matcha vaporiser outlet 3260 in a posterior side of the vaporiser module5500. One or more connecting surfaces 3451 surround the vaporiser outlet3260 and are structured to sealingly mate with complementary connectingsurfaces on the plenum chamber 3200 surrounding the opening therein.

The vaporiser module 5500 may be configured to be removably coupled tothe patient interface 3000, such as with the plenum chamber 3200. Thevaporiser module 5500 may comprise a tab 3450 configured to be receivedby the patient interface, or to be connectable to the patient interfacevia a snap fit. The connecting surfaces of the plenum chamber 3200and/or the vaporiser module 5500 may comprise one or more flanges and/orseals to facilitate a substantially sealed connection therebetween.

It will be appreciated that the connection port or inlet of the patientinterface 3000 may be indirectly connected to air circuit 4170 throughthe vaporiser module 5500, as is the case in the forms of the technologyshown in FIGS. 8D and 8E.

Vaporiser module 5500 may comprise a vaporiser housing 3410 as shown inFIGS. 8A and 8B. The vaporiser housing 3410 may comprise a vent 3400,for example positioned on its anterior side during use, and a vaporiseroutlet 3260, for example positioned on its posterior side during use.The vaporiser housing 3410 may be adapted to removably engage to aplenum chamber 3200 of patient interface 3000. The vaporiser housing3410 may locate the vaporiser module 5500 in a flow path of breathablegas within a plenum chamber 3200 of the patient interface 3000 and mayorient the heating element 5530 of the vaporiser module 5500 to besubstantially in line with or parallel to a flow path of the flow ofbreathable gas, thereby allowing flow through the vaporiser module 5500.The positioning of the vaporiser module 5500 in close proximity to theentrance of the patient's airways may maximise the efficiency of thehumidification of the breathable air from RPT device 4000 and minimisethe opportunity for humidified air exiting the vaporiser module 5500from condensing to liquid water prior to being inhaled by the patient1000.

A vaporiser housing 3410 comprising vaporiser module 5500 shown in FIG.8B, and shown in engagement respectively with a pillows-type patientinterface 3001 and a full-face-type patient interface 3003 in FIGS. 8Dand 8E, may fluidly connect an interior chamber of the vaporiser module5500 with the plenum chamber 3200 of the patient interface 3000 and maydivide said plenum chamber 3200 into an anterior side of the plenumchamber and a posterior side of the plenum chamber. This positioning ofthe vaporiser module 5500 may position the vent 3400 on an anterior(upstream, i.e. humidifier) side of the heating element 5530 during usewith the entrance of the patient's airways on a posterior (downstream,i.e. patient) side of the vaporiser module 5500. This configuration mayallow the flow of exhaled gas from the patient to flow into theposterior side of the plenum chamber prior to venting, which allows anywater vapour in the exhaled air to be retained in the heating element5530 prior to being lost out of the vent 3400. This recaptured watervapour may then be re-vaporised by heating element 5530 and may enterthe air flow of the patient's next inhalation, thus assisting theefficiency of the humidifier 5000 by not requiring as much water in theform of nebula 5300 delivered from nebuliser module 5100 in order toproduce breathable air of sufficient humidity for the comfort of patient1000.

It is also possible to position an auxiliary vent on the posterior sideof the vaporiser module 5500 in the plenum chamber 3200 to offset CO₂build up within this volume. For example, in the case of a full facemask, the additional volume in the plenum chamber 3200 (i.e., dead spacevolume) in comparison to smaller masks, may lead to unwanted and/orexcessive CO₂ build up occurring within this space. To mitigate thiseffect, an auxiliary vent may be positioned proximal to the patient'sairways, on the posterior or patient side of the vaporiser module 5500.Positioning an auxiliary vent on the posterior side of the vaporisermodule 5500 will result in some venting of the humidified flow ofbreathable gases prior to delivery to the patient. To compensate forthis venting of humidified air, the overall humidification performancemay be maintained by increasing the ability of the vaporiser module 5500and/or nebuliser module 5100 to humidify the flow of breathable gaswithin a predetermined volume of the plenum chamber 3200.

The vaporiser housing 3410 may also include a baffle to separate theincoming flow of breathable gas from the flow of CO₂ washout. The bafflemay separate these flows of gas from one another such that these flowsof gas do not interfere with one another. U.S. Pat. No. 7,934,501, whichis incorporated herein by reference in its entirety, describes furtherexamples and features of baffles that may be applicable to the exemplarypatient interface 3000.

FIGS. 8E and 8F show schematic cross-sectional views of vaporiser module5500 along line A-A of FIG. 8B. A vaporiser inlet 3250 of vaporisermodule 5500 is pneumatically connected to the distal end of air circuit4170 by a connection collar 4172. Air circuit 4170 comprises wirecircuits 4171 to provide power and signalling to vaporiser module 5500.Wire circuits 4171 are contained within helically wound ribs 4173 onouter surface of air conduit 4170. In use, aerosol droplets of liquidwater in nebula 5300 are transported by airflow 5400 along air circuit4170 to vaporiser module 5500. Liquid water droplets on reachingvaporiser module 5500 are vaporised by the heating element 5530. In someforms, the heating element 5530 is formed from a thermally conductivematerial. In some forms, the heating element 5530 presents alabyrinthine path for nebula 5300 and airflow 5400 to improve theadsorption of liquid water droplets of nebula 5300 onto a surface of theheating element 5530, and to improve vaporisation of the adsorbed nebula5300 into the air path. In some forms, the heating element 5530comprises one or more of: a metal, a polymer, or a ceramic. Suitableexamples of heating element 5530 may include a metal foam, or a porouspolymer.

FIGS. 9A and 9B are illustrations of a vaporiser module 5500 accordingto certain forms of the present technology. In particular arrangements,the vaporiser module 5500 may be in the form of an in-line module, i.e.positioned in the air circuit in the path of the air flow, distal fromthe patient interface 3000. Vaporiser module 5500 comprises a vaporiserinlet 3250 configured to fluidly connect to an upstream portion of anair circuit 4170 for receiving a nebula 5300 in a flow of air from anebuliser module 5100. Vaporiser module 5500 further comprises avaporiser outlet 3260 configured to fluidly connect to a downstreamportion of an air circuit 4170 for delivering a humidified flow of airto a patient interface 3000. Vaporiser module 5500 may also comprisehumidifier sensors 5210 and a protective cover 5220 for the humidifiersensors 5210. The humidifier sensors 5210 may provide feedback signalsto the humidifier controller 5250. The humidifier sensors 5210, as shownin FIG. 9B, may be located on a rectangular protrusion and positioned inthe air flow path. PCB 5540 may be located in the vaporiser module 5500,as shown in FIG. 9B. PCB 5540 may be configured to have a shape in orderthat it is able to fit compactly in the vaporiser module 5500. Forexample, as shown in FIG. 9B, PCB 5540 is shaped to fit around the outercircumference of the air flow path through vaporiser module 5500.

Vaporiser module 5500 may also comprise a heating element 5530 and ahousing 5535 for the heating element 5530. In some forms, the heatingelement 5530 is in the form of a pin array 5531, as shown in FIG. 9B.The heating element 5530 comprising a central plate 5532 from whichpin-shaped projections extend on one or (in the case of the embodimentof FIG. 9B) both sides of the central plate 5532. In the form of thetechnology shown in FIG. 9B the pins extend parallel to a longitudinalaxis of the vaporiser module 5500 and parallel to the direction of airflow through the vaporiser module 5500. In other forms of the technologythe pins of pin array 5531 extend in another direction, for exampleperpendicular to the direction of air flow. The central plate 5532 maycomprise a film heater to heat the pin array 5531. In the embodimentshown in FIG. 9B the central plate 5532 is arranged inside vaporisermodule 5500 so that there is a space or spaces between its outercircumference and the inner walls of housing 5535 for the flow of air topass around it. The pin array 5531 provides a large surface area forcontact between the heating element 5530 and the nebula in the flow ofair.

In some forms, the heating element 5530 has a structure to provide atortuous air path. For example, the heating element may be helicoid. Theaxis of the helicoid may be parallel to the direction of the flow of airthrough the vaporiser module 5500. The helicoid structure may comprise arod heater at its centre to heat the heating element 5530.

In some forms, the heating element 5530 is formed of a high electricalimpedance material, in which case it may be connected to an electricalcircuit and be heated by resistive heating to vaporise the adsorbednebula 5300. One suitable example may be a resistive, porous ceramicelement. In alternative forms, the heating element 5530 is formed of alow electrical impedance material and a second heating component may beneeded. A second heating component may be provided in the vaporisermodule 5500 and thermally coupled to the heating element 5530 to provideheat for vaporisation of the nebula 5300. In one form, the secondheating component is provided in direct contact with the heating element5530 such that in operation the second heating component heats heatingelement 5530 to facilitate vaporisation of liquid water dropletsadsorbed onto a surface of the heating element 5530. Airflow 5400 as itpasses through heating element 5530 takes up the vaporised waterdroplets to form a humidified airflow 5410 exiting vaporiser module 5500to be delivered at a controllable temperature and humidity to patientinterface 3000 for inhalation by patient 1000. Heating element 5530 maybeneficially provide heat to airflow 5400 as it passes therethrough fordelivery to the patient at a comfortable temperature.

A potential disadvantage of transporting liquid water to a pointproximal to patient interface 3000 is that liquid water can transportbacteria which may undesirably be inhaled by patient 1000. Incomparison, bacteria cannot be transported by water vapour in ahumidified flow of air. Accordingly, particular care must be taken withthe operation of vaporiser module 5500 to ensure that all liquid waterdroplets of nebula 5300 is adsorbed by a heating element 5530 andvaporised into water vapour to prevent the possible transfer of bacteriato patient 1000. Optionally, a liquid filter 5600 may be provideddownstream of the heating element 5530. Filter 5600 is adapted such thatwater vapour is permitted to pass through filter 5600, but residualliquid water which may pass through heating element 5530 is blocked byfilter 5600, thus reducing any potentially bacteria-laden liquid waterdroplets reaching the patient 1000. In further arrangements, where anoptional HMX 5510 may be provided in vaporiser module 5500, the HMX 5510would also act as a liquid filter only allowing humidified aircontaining water vapour to pass therethrough.

4.5.3 Oxygen Delivery

In one form of the present technology, supplemental oxygen 4180 isdelivered to one or more points in the pneumatic path, such as upstreamof the pneumatic block 4020, to the air circuit 4170 and/or to thepatient interface 3000.

4.6 Certain Advantages of the Technology

An advantage of certain forms of the present technology is reducing oreliminating a need to heat the air circuit or a humidifier tub.

In prior devices, which require the heating of a large volume of waterto humidify the air supply, it can take a long time for the level ofhumidity to be acceptable for patient breathing. An advantage of certainforms of the present technology is a more rapid change in the level ofhumidity, compared to prior art devices.

An advantage of certain forms of the present technology compared toprior devices which require heating liquid in a humidifier tub, is thatthere is a reduced risk of overheating of a reservoir, and potentiallydamaging a bedside table, the humidifier and/or the RPT device. Forexample, as can be caused if the liquid in the reservoir is exhaustedbut a heating element keeps emitting heat. In the presently describedtechnology, should the reservoir run dry the only consequence is thepatient receives dry air.

An advantage of the certain forms of the present technology compared toprior devices is that the addition of a nebula to the airflow providescooling of the airflow via evaporative cooling mechanisms. It istherefore possible to provide air to the patient which is below ambientair temperature, which may be beneficial under particular circumstances,such as in hot climates.

4.7 GLOSSARY

For the purposes of the present technology disclosure, in certain formsof the present technology, one or more of the following definitions mayapply. In other forms of the present technology, alternative definitionsmay apply.

4.7.1 General

Air: In certain forms of the present technology, air may be taken tomean atmospheric air, and in other forms of the present technology airmay be taken to mean some other combination of breathable gases, e.g.atmospheric air enriched with oxygen.

Ambient: In certain forms of the present technology, the term ambientwill be taken to mean (i) external of the treatment system or patient,and (ii) immediately surrounding the treatment system or patient.

For example, ambient humidity with respect to a humidifier may be thehumidity of air immediately surrounding the humidifier, e.g. thehumidity in the room where a patient is sleeping. Such ambient humiditymay be different to the humidity outside the room where a patient issleeping.

In another example, ambient pressure may be the pressure immediatelysurrounding or external to the body.

In certain forms, ambient (e.g., acoustic) noise may be considered to bethe background noise level in the room where a patient is located, otherthan for example, noise generated by an RPT device or emanating from amask or patient interface. Ambient noise may be generated by sourcesoutside the room.

Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressuretherapy in which the treatment pressure is approximately constantthrough a respiratory cycle of a patient. In some forms, the pressure atthe entrance to the airways will be slightly higher during exhalation,and slightly lower during inhalation. In some forms, the pressure willvary between different respiratory cycles of the patient, for example,being increased in response to detection of indications of partial upperairway obstruction, and decreased in the absence of indications ofpartial upper airway obstruction.

Flow rate: The volume (or mass) of air delivered per unit time. Flowrate may refer to an instantaneous quantity. In some cases, a referenceto flow rate will be a reference to a scalar quantity, namely a quantityhaving magnitude only. In other cases, a reference to flow rate will bea reference to a vector quantity, namely a quantity having bothmagnitude and direction. Flow rate may be given the symbol Q. ‘Flowrate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

Humidifier: The word humidifier will be taken to mean a humidifyingapparatus constructed and arranged, or configured with a physicalstructure to be capable of providing a therapeutically beneficial amountof water (H₂O) vapour to a flow of air to ameliorate a medicalrespiratory condition of a patient.

Leak: The word leak will be taken to be an unintended flow of air. Inone example, leak may occur as the result of an incomplete seal betweena mask and a patient's face. In another example leak may occur in aswivel elbow to the ambient.

Patient: A person, whether or not they are suffering from a respiratorycondition.

Pressure: Force per unit area. Pressure may be expressed in a range ofunits, including cmH₂O, g-f/cm² and hectopascal. 1 cmH₂O is equal to 1g-f/cm² and is approximately 0.98 hectopascal. In this specification,unless otherwise stated, pressure is given in units of cmH₂O.

4.7.1.1 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In thisspecification, a reference to silicone is a reference to liquid siliconerubber (LSR) or a compression moulded silicone rubber (CMSR). One formof commercially available LSR is SILASTIC (included in the range ofproducts sold under this trademark), manufactured by Dow Corning.Another manufacturer of LSR is Wacker. Unless otherwise specified to thecontrary, an exemplary form of LSR has a Shore A (or Type A) indentationhardness in the range of about 35 to about 45 as measured using ASTMD2240.

Polycarbonate: a thermoplastic polymer of Bisphenol-A Carbonate.

4.7.2 Patient Interface

Anti-asphyxia valve (AAV): The component or sub-assembly of a masksystem that, by opening to atmosphere in a failsafe manner, reduces therisk of excessive CO₂ rebreathing by a patient.

Elbow: An elbow is an example of a structure that directs an axis offlow of air travelling therethrough to change direction through anangle. In one form, the angle may be approximately 90 degrees. Inanother form, the angle may be more, or less than 90 degrees. The elbowmay have an approximately circular cross-section. In another form theelbow may have an oval or a rectangular cross-section. In certain formsan elbow may be rotatable with respect to a mating component, e.g. about360 degrees. In certain forms an elbow may be removable from a matingcomponent, e.g. via a snap connection. In certain forms, an elbow may beassembled to a mating component via a one-time snap during manufacture,but not removable by a patient.

Plenum chamber: a mask plenum chamber will be taken to mean a portion ofa patient interface having walls at least partially enclosing a volumeof space, the volume having air therein pressurised above atmosphericpressure in use. A shell may form part of the walls of a mask plenumchamber.

Seal: May be a noun form (“a seal”) which refers to a structure, or averb form (“to seal”) which refers to the effect. Two elements may beconstructed and/or arranged to ‘seal’ or to effect ‘sealing’therebetween without requiring a separate ‘seal’ element per se.

Shell: A shell will be taken to mean a curved, relatively thin structurehaving bending, tensile and compressive stiffness. For example, a curvedstructural wall of a mask may be a shell. In some forms, a shell may befaceted. In some forms a shell may be airtight. In some forms a shellmay not be airtight.

Vent: (noun): A structure that allows a flow of air from an interior ofthe mask, or conduit, to ambient air for clinically effective washout ofexhaled gases. For example, a clinically effective washout may involve aflow rate of about 10 litres per minute to about 100 litres per minute,depending on the mask design and treatment pressure.

4.8 Other Remarks

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilised to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being used to construct acomponent, obvious alternative materials with similar properties may beused as a substitute. Furthermore, unless specified to the contrary, anyand all components herein described are understood to be capable ofbeing manufactured and, as such, may be manufactured together orseparately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated herein by referencein their entirety to disclose and describe the methods and/or materialswhich are the subject of those publications. The publications discussedherein are provided solely for their disclosure prior to the filing dateof the present application. Nothing herein is to be construed as anadmission that the present technology is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dates,which may need to be independently confirmed.

The terms “comprises” and “comprising” should be interpreted asreferring to elements, components, or steps in a non-exclusive manner,indicating that the referenced elements, components, or steps may bepresent, or utilised, or combined with other elements, components, orsteps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular examples, it is to be understood that these examples aremerely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative examples and that other arrangements may be devisedwithout departing from the spirit and scope of the technology.

1-10. (canceled)
 11. A respiratory treatment system for providing a flowof air at positive pressure to a patient for treatment of sleepdisordered breathing, the system comprising: a vaporizer apparatuscomprising: a vaporizer inlet for receiving a nebula in a flow of air ata positive pressure with respect to ambient pressure; a heating elementconfigured to generate heat to vaporize the received nebula to humidifythe flow of air; and a vaporizer outlet configured to fluidly connect toa downstream patient interface such that, in use, the humidified flow ofair exits the vaporizer apparatus via the vaporizer outlet in adirection towards the patient interface; and a patient interfaceconfigured to receive the humidified flow of air form the vaporizeroutlet and deliver the humidified flow of air to an airway of thepatient, wherein the patient interface includes one or more surfacesaround an opening in the patient interface, the vaporizer apparatusbeing directly connectable to the patient interface such that the one ormore surfaces of the patient interface are configured to structurallysupport and hold the vaporizer apparatus in position on the patientinterface.
 12. The respiratory treatment system of claim 11, wherein theopening in the patient interface is on an anterior side of the patientinterface during use.
 13. The respiratory treatment system of claim 11,wherein the opening in the patient interface is shaped and structured tocorrespond to a shape and structure of the vaporizer outlet.
 14. Therespiratory treatment system of claim 11, wherein one or more connectingsurfaces are disposed around the vaporizer outlet and are configured tosealing mate with the one or more surfaces of the patient interface. 15.The respiratory treatment system of claim 11, wherein the patientinterface includes a plenum chamber, and the opening in the patientinterface is formed in the plenum chamber.
 16. The respiratory treatmentsystem of claim 11, wherein the vaporizer apparatus is removablyconnectable to the patient interface with a snap-fit.
 17. Therespiratory treatment system of claim 11, wherein the patient interfaceincludes a plenum chamber, and the opening in the patient interface isformed in the plenum chamber, and wherein the vaporizer apparatusincludes a housing, the housing being configured to be removablyconnected to the plenum chamber of the patient interface.
 18. Therespiratory treatment system of claim 11, wherein the vaporizerapparatus includes a vent for washout of exhaled gas.
 19. Therespiratory treatment system of claim 18, wherein the vent is positionedon an upstream side of the heating element.
 20. The respiratorytreatment system of claim 18, wherein the vaporizer apparatus includes abaffle to separate the humidified flow of air from a flow of the exhaledgas.
 21. The respiratory treatment system of claim 11, wherein theheating element is formed of a thermally conductive material comprisinga metal, a polymer, or a ceramic.
 22. The respiratory treatment systemof claim 11, wherein the vaporizer apparatus comprises a labyrinthineflow path therethrough for the nebula and the flow of air to allow foradsorption of liquid water droplets of the nebula onto a surface of theheating element.
 23. The respiratory treatment system of claim 11,wherein the vaporizer apparatus comprises one or more sensors configuredto sense one or more parameters of the humidified flow of air, andwherein the one or more parameters comprise one or more of: temperature;flow rate; pressure; and humidity of the humidified flow of air.
 24. Therespiratory treatment system of claim 11, wherein the vaporizer modulecomprises a heat and moisture exchange (HMX) module.
 25. The respiratorytreatment system of claim 11, wherein the patient interface is afull-face patient interface.
 26. The respiratory treatment system ofclaim 11, wherein the patient interface is a nasal interface.
 27. Therespiratory treatment system of claim 26, wherein the nasal interface isa pillows-type patient interface.
 28. The respiratory treatment systemof claim 11, further comprising a nebulizer module including a waterreservoir configured to retain a volume of water, the nebulizer modulebeing configured to receive water from the water reservoir, generate anebula, and admit the nebula into the flow of air.
 29. The respiratorytreatment system of claim 28, wherein the vaporizer inlet is configuredto fluidly connect to an upstream portion of an air circuit to receivethe nebula.
 30. The respiratory treatment system of claim 11, whereinthe opening in the patient interface is on an anterior side of thepatient interface during use, wherein the opening in the patientinterface is shaped and structured to correspond to a shape andstructure of the vaporizer outlet, wherein one or more connectingsurfaces are disposed around the vaporizer outlet and are configured tosealing mate with the one or more surfaces of the patient interface,wherein the patient interface includes a plenum chamber, and the openingin the patient interface is formed in the plenum chamber, wherein thevaporizer apparatus includes a housing, the housing being configured tobe removably connected to the plenum chamber of the patient interfacewith a snap-fit, wherein the vaporizer apparatus includes a vent forwashout of exhaled gas, the vent being positioned on an upstream side ofthe heating element, wherein the vaporizer apparatus includes a baffleto separate the humidified flow of air from a flow of the exhaled gas,and wherein the vaporizer apparatus comprises a labyrinthine flow paththerethrough for the nebula and the flow of air to allow for adsorptionof liquid water droplets of the nebula onto a surface of the heatingelement.